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Development, validation and clinical application of a novel tumor marker (UCseek) for non-invasive diagnosis and recurrence monitoring of urothelial carcinoma in a Chinese population

Development, validation and clinical application of a novel tumor marker (UCseek) for non-invasive diagnosis and recurrence monitoring of urothelial carcinoma in a Chinese population

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200063932
Enrollment
Unknown
Registered
2022-09-21
Start date
2022-09-13
Completion date
Unknown
Last updated
2023-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urothelial carcinoma (UC)

Interventions

Gold Standard:The final pathological diagnosis is taken as the gold standard: urothelial carcinoma is positive, non-urothelial carcinoma is negative, and other malignant tumors are excluded.
Index test:UCseek is a detection model combined methylation haploid load (MHL) with CNV. The UCseek score cutoff value is 0.46. If the score is more than 0.46, the patient would be classfied to urothe

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. The experimental group: Patients who were initially diagnosed with urothelial carcinoma by clinical imaging (CT or MRI), and planned to undergo surgical treatment, and were finally confirmed as urothelial carcinoma by postoperative pathology. 2. The control group: Non-neoplastic diseases of the urinary system were excluded clinically (imaging and blood tumor markers ).

Exclusion criteria

Exclusion criteria: 1. Experimental group: (1) The patient has contraindications to surgery, so radical surgery cannot be performed to obtain pathology; (2) The patient had a history of bladder cancer, prostate cancer and other malignant tumors of the urinary system; (3) The patient proposed radical bladder resection in the short term and could not complete the follow-up study; (4) The patient refused to sign the informed consent and participate in the clinical study. 2. Control group: (1) Patients with bladder cancer, prostate cancer and other malignant tumors of urinary system; (2) The patient refused to sign the informed consent and participate in the clinical study.

Design outcomes

Primary

MeasureTime frame
Sensitivity;

Secondary

MeasureTime frame
Specificity;Positive predictive value;Negative predictive value;Overall consistency;

Countries

China

Contacts

Public ContactZhou Liqun

Peking University First Hospital

zhoulqmail@sina.com+86 13601239241

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026